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A drug developed to treat bleeding in the oesophagus is a step closer to receiving approval from the US drugs watchdog.
Debiovision Inc, a Canadian division of the Debiopharm Group, announced its has filed its Complete Response to the approvable letter received from the US Food and Drug Administration (FDA) concerning the drug Sanvar (vapreotide acetate).
The drug is used to control haemorrhaging in cases of acute oesophageal variceal bleeding. It is a somatostatin analogue that can be stored at room temperature, which gives it a distinct advantage over other products requiring refrigeration as it allows for immediate administration in life-threatening situations.
Rolland-Yves Mauvernay, president and founder of Debiopharm Group, said: “This is an important step towards completing the US registration of our drug.
“Sanvar has demonstrated therapeutic benefit in the control of acute variceal bleeding prior to endoscopic treatment, an indication for which, to this day, no product has been approved by the FDA.”
Debiopharm has already signed licence agreements for the sales and marketing of Sanvar with several commercial partners that include Salix Pharmaceuticals in the US, Ranbaxy Laboratories Ltd in India, EMS Sigma Farma in Brasil, LG Life Sciences in Korea, Tzamal Bio-Pharma Ltd in Israel, and Medical Futures in Canada.
Copyright Press Association 2008